Surgeon Experience ReSTOR A +4 Intraocular Lens (IOL)

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00733512
• Collaborator: (none)
• Enrollment: 146
• Location: 1
• Duration (Months): 9
• Patients Per Site Per Month: 16.2

Study Details

Study Description

Brief Summary

To collect visual outcome data post AcrySof ReSTOR Aspheric +4 implantation from surgeons throughout the United States.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: ReSTOR

Study Design

• Study Type: Observational
• Actual Enrollment: 146 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Surgeon Experience ReSTOR Aspheric +4 Intraocular Lens (IOL)
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
ReSTOR AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)	Device: ReSTOR; Patients were implanted with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL) in one or both eyes for treatment of cataract.

Outcome Measures

Primary Outcome Measures

1. Visual Acuity [1 week to 10 months]

   Uncorrected Visual Acuity (UCVA) and Best Spectacle Corrected Visual Acuity (BSCVA) at distance (4 meters) and near at preferred distance and measured by logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.

Secondary Outcome Measures

1. Contrast Sensitivity [1 week to 10 months]

   Contrast sensitivity is the measurement of how faded an image may become before it is indistinguishable. Contrast sensitivity was measured in photopic, mesopic, and mesopic with glare conditions at the following spatial frequencies: 1.5, 3, 6, 12, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• operable cataracts; candidate for presbyopic correcting intraocular lens (IOL)

Exclusion Criteria:

• ocular comorbidities confounding study outcomes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Call Center for Trial Locations	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00733512
• Other Study ID Numbers: M07-019
• First Posted: Aug 13, 2008
• Last Update Posted: Mar 27, 2017
• Last Verified: Apr 1, 2010

• Keywords provided by Alcon Research: ReSTOR Aspheric +4 IOL
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	Subjects 18 years of age and older of either sex and any race. Diagnosis of cataracts in one or both eyes.
Pre-assignment Detail	Subjects eligibility was determined at the preoperative visit.

Arm/Group Title	ReSTOR
Arm/Group Description	Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
Period Title: Overall Study
STARTED	146
COMPLETED	146
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	ReSTOR
Arm/Group Description	Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
Overall Participants	146
Age, Customized (participants) [Number]
<=18 years	0 0%
Between 18 and 65 years	65 44.5%
>=65 years	59 40.4%
Sex/Gender, Customized (participants) [Number]
Female	79 54.1%
Male	54 37%

Outcome Measures

1. Primary Outcome

Title	Visual Acuity
Description	Uncorrected Visual Acuity (UCVA) and Best Spectacle Corrected Visual Acuity (BSCVA) at distance (4 meters) and near at preferred distance and measured by logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.
Time Frame	1 week to 10 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ReSTOR
Arm/Group Description	Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
Measure Participants	146
Distance (4 meters) UCVA	0.07 (0.12)
Near (preferred distance) UCVA	0.07 (0.11)
Distance (4 meters) BSCVA	0.02 (0.10)
Near (preferred distance) BSCVA	0.06 (0.11)

2. Secondary Outcome

Title	Contrast Sensitivity
Description	Contrast sensitivity is the measurement of how faded an image may become before it is indistinguishable. Contrast sensitivity was measured in photopic, mesopic, and mesopic with glare conditions at the following spatial frequencies: 1.5, 3, 6, 12, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.
Time Frame	1 week to 10 months

Outcome Measure Data

Analysis Population Description

contrast sensitivity data was received for only 51 of 146 patients.

Arm/Group Title	ReSTOR
Arm/Group Description	Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
Measure Participants	51
Photopic condition at 1.5 cpd	1.61 (0.31)
Photopic condition at 3 cpd	1.78 (0.32)
Photopic condition at 6 cpd	1.72 (0.44)
Photopic condition at 12 cpd	1.22 (0.53)
Photopic condition at 18 cpd	0.70 (0.57)
Mesopic condition at 1.5 cpd	1.69 (0.30)
Mesopic condition at 3 cpd	1.69 (0.32)
Mesopic condition at 6 cpd	1.43 (0.57)
Mesopic condition at 12 cpd	0.66 (0.67)
Mesopic condition at 18 cpd	0.25 (0.45)
Mesopic with glare condition at 1.5 cpd	1.29 (0.52)
Mesopic with glare condition at 3 cpd	1.28 (0.58)
Mesopic with glare condition at 6 cpd	0.92 (0.74)
Mesopic with glare condition at 12 cpd	0.27 (0.57)
Mesopic with glare condition at 18 cpd	0.07 (0.27)

Adverse Events

Adverse Event Reporting Description	Adverse events were not collected for this study because there was no intervention. This was a data collection only study.
Arm/Group Title	ReSTOR
Arm/Group Description	Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
All Cause Mortality
	ReSTOR
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	ReSTOR
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	ReSTOR
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

No paper that incorporates Sponsor Confidential information will be submitted for publication without Sponsor's prior written agreement.